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A Phase II, Multicenter, Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF (Bevacizumab), a Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor, in Combination With 5-Fluorouracil and Leucovorin Chemotherapy in Subjects With Metastatic Colorectal Cancer Who Are Not Optimal Candidates for First Line CPT-11


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

A Phase II, Multicenter, Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF (Bevacizumab), a Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor, in Combination With 5-Fluorouracil and Leucovorin Chemotherapy in Subjects With Metastatic Colorectal Cancer Who Are Not Optimal Candidates for First Line CPT-11


Inclusion Criteria:



- Written informed consent

- Age >=18 years

- Use of an effective means of contraception in women of childbearing potential

- Histologically confirmed (resected or biopsied primary tumor) colorectal carcinoma
with evidence of metastases (i.e., by radiographic imaging or biopsy)

- Ability to tolerate CT contrast dye.

- Bi-dimensionally measurable disease (minimum of two lesions)

- Life expectancy of >3 months

- Willingness and capability to be accessible for follow-up until death

- In addition, subjects must meet at least one of the following criteria to be eligible
for study entry: *Age >=65 years; *ECOG performance status of 1 or 2; *Albumin <=3.5
g/dL; *Prior radiotherapy to the abdomen or pelvis; and, *in the opinion of the
treating physician, not be an optimal candidate for first-line CPT-11

Exclusion Criteria:

- Prior administration of chemotherapy other than adjuvant fluoropyrimidines in
combination with leucovorin and/or levamisole

- Administration of adjuvant fluoropyrimidines in combination with leucovorin and/or
levamisole completed <=12 months prior to Day 0

- Administration of fluoropyrimidines as a radiosensitizer during pelvic radiotherapy
for rectal cancer completed <=12 months prior to Day 0

- Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure
response

- Radiotherapy within 14 days prior to Day 0

- Prior administration of biotherapy for colorectal cancer

- Evidence of clinically detectable ascites prior to Day 0

- Other invasive malignancies within 5 years of Day 0 (other than basal cell carcinoma
of the skin)

- History or evidence upon physical examination of CNS disease (e.g., primary brain
tumor, seizures not controlled with standard medical therapy, or any brain
metastases)

- Serious, nonhealing wound, ulcer, or bone fracture

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure within 28 days prior to Day 0, or open biopsy, significant
traumatic injury, or anticipation of need for major surgical procedure during the
course of the study; fine needle aspirations within 7 days prior to Day 0

- Current or recent (within the 10 days prior to Day 0) use of oral or parenteral
anticoagulants (except as required to maintain patency of preexisting, permanent
indwelling IV catheters) or thrombolytic agent

- Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory
medications (of the kind known to inhibit platelet function)

- Pregnancy (positive pregnancy test) or lactation

- Proteinuria at baseline or clinically significant impairment of renal function

- Current or recent (within 28 days prior to Day 0) participation in another
experimental drug study

- Active infection requiring parenteral antibiotics on Day 0

- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II
or greater congestive heart failure (see Appendix H), serious cardiac arrhythmia
requiring medication, or Grade II or greater peripheral vascular disease within 1
year prior to Day 0

- ECOG performance status of >2

- Screening clinical laboratory values: *ANC of <=1500/uL; *Platelet count of
<=75,000/uL; *International normalized ratio (INR) of >=1.5; *Total bilirubin of >2.0
mg/dL; *AST or ALT of >=5 times the upper limit of normal for subjects with
documented liver metastases; >2.5 times the upper limit of normal for subjects
without evidence of liver metastases; *Serum creatinine of >2.0 mg/dL; *Hemoglobin of
<9 gm/dL (may be transfused to maintain or exceed this level); *Proteinuria (24-hour
urine collection demonstrated >=500 mg of protein/24 hr)

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect
interpretation of the results of the study or render the subject at high risk from
treatment complications

- Inability to comply with the study visit and follow-up schedule or procedures

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

AVF2192g

NCT ID:

NCT00109226

Start Date:

August 2000

Completion Date:

September 2003

Related Keywords:

  • Colorectal Cancer
  • Metastatic Colorectal Cancer
  • Cancer
  • Colorectal Neoplasms

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